Percutaneous access of the vascular system for vascular device delivery is a common medical procedure. Typically this involves using a hollow needle to puncture the skin and a vessel, then introducing an introducer sheath to open the puncture site for the introduction of catheters and wire guides for navigation through the vascular system to facilitate delivery of suitable interventional devices. In many cases, vascular access requires introduction of catheters and wire guides through the femoral artery. Once the appropriate interventional procedure is completed, the introducer sheath is removed, sutures are applied to the puncture site and knotted to close the wound, and pressure is applied to the puncture site to stop the bleeding.
There are several disadvantages to the existing methodologies for treating cutaneous wounds. Achieving hemostasis with manual compression can be difficult, painful, and time-consuming. Moreover, removal of sutures may be difficult and painful, given their capacity to become buried within the tissues around the puncture site. In addition, in view of the close proximity of many cutaneous suture knots to high flow hemodialysis access sites, nurse practitioners may be reluctant to remove such sutures, thereby requiring additional attention by a doctor or secondary visits to the clinic or hospital. Although purse-string suture techniques are helpful for hemostasis, achieving precise tension on the sutures can be challenging.
In many cases, a purse-string suture technique is utilized to close wounds and promote hemostasis following hemodialysis treatment. Zaleski et al. discloses a modified purse-string suture technique involving placement of a miniature plastic dilator from a vascular sheath below a purse string suture to act as a “tourniquet”, allowing tension on the purse-string suture to be adjusted by clockwise rotation of the tourniquet (Zaleski et al., AJR, Vol. 175, pp. 1643-1645, 2000). Following adjustment of the tension, the tourniquet is taped down and the sutures are left in place for a minimum of 24 hr., preferably 48-72 hours, before being removed, typically at the next dialysis session.
WO 2009/114811 A2 to Lampropoulos et al. discloses an elaborate suture securement system adapted for use with purse-string sutures. The system includes a suture securement apparatus 10 in conjunction with a threading assembly 20 (see, for example, FIG. 1). The suture securement apparatus includes a body employing a spring biased suture securing system that is connected to an extension tube for facilitating tensioning of the sutures at the suture insertion site. The threading assembly includes a suture loop functioning as a snare for pulling free suture tail ends into the suture securement apparatus. The elaborate system described by Lampropoulos includes many interacting components and does not appear to readily lend itself to hands-free use until hemostasis is achieved.
It would be advantageous and economical to eliminate unnecessary components or method steps in the design of a simple, easy to use, hands-free wound closure device. The present invention addresses the above-described problems and shortcomings, and provides a simple, easily manufactured device that can be easily deployed without leaving behind sutures or requiring the need for additional visits.